TEST ITEMS

 SPECIFICATION

RESULTS

Description

White or Almost White Crystalline Powder

Conforms

Identification

A.B.

Positive

Assay

97.0~102.0%

99.07%

Specific Rotation

+104°~+112°

'+107.8°

Loss On Drying

1.0%max

0.36%

Chromatographic Purity

single impurity:1.0%max

<1.0%

total impurities:2.0%max

<2.0%

Organic Volatile Impurities

meets the requirement

Conforms

Residual Solvents

meets the requirement.(USP29)

Conforms

Conclusion

The specification conform with USP32 standard